Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange
ECLIPSE
1 other identifier
observational
48
1 country
1
Brief Summary
Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedApril 13, 2010
April 1, 2010
11 months
June 22, 2009
April 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of plasma isoprostane and lipoperoxides
at baseline
Secondary Outcomes (1)
TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL
2 hours
Study Arms (4)
type 2 diabetics with metabolic syndrome
metabolic syndrome without diabetes
type 1 diabetes
control
Interventions
Blood sample for lipidomic study
Eligibility Criteria
group 1: type 2 diabetics with metabolic syndrome group 2: metabolic syndrome without diabetes group 3: subjects with type 1 diabetes group 4: controls
You may qualify if:
- statin and fibrate Wash out for one week
- HbA1c\>7% and \<12% (Arms 1 and 3)
- HbA1c\<6% (Arms 2 and 4)
- Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2)
You may not qualify if:
- secondary CV prevention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique
Lyon, 69394, France
Related Publications (1)
Colas R, Sassolas A, Guichardant M, Cugnet-Anceau C, Moret M, Moulin P, Lagarde M, Calzada C. LDL from obese patients with the metabolic syndrome show increased lipid peroxidation and activate platelets. Diabetologia. 2011 Nov;54(11):2931-40. doi: 10.1007/s00125-011-2272-8. Epub 2011 Aug 17.
PMID: 21847583DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe MOULIN, MD, PhD
Hospices Civils de Lyon
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2009
First Posted
July 2, 2009
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
April 13, 2010
Record last verified: 2010-04